ESWT for UE Pain in Patients With Cervical Spinal Cord Injury

Overview

This study aimed to investigate the efficacy and safety of extracorporeal shockwave therapy (ESWT) for upper extremity pain related to spasticity in patients with spinal cord injury.

Full Title of Study: “The Effects of Extracorporeal Shockwave Therapy (ESWT) for Upper Extremity Pain Related to Spasticity in Patients With Spinal Cord Injury”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 31, 2020

Detailed Description

6 times of ESWT (3,000 pulses per time, low energy under 0.3 mJ/m^2, tolerable range) on forearm area to reduce pain related to spasticity in patients with cervical myelopathy

Interventions

  • Device: Extracorporeal shockwave therapy
    • 6 times during 2 weeks
  • Device: Sham therapy
    • 6 times during 2 weeks

Arms, Groups and Cohorts

  • Experimental: Experimental group
    • 3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range
  • Sham Comparator: Control group
    • Sham therapy

Clinical Trial Outcome Measures

Primary Measures

  • Numerical rating scale (NRS)
    • Time Frame: Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
    • Pain intensity (0-10, ordinal scale)

Secondary Measures

  • Modified Ashworth scale (MAS)
    • Time Frame: Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
    • Spasticity, ordinal scale (0, 1, 1+, 2, 3, 4: higher scores indicate more severe spasticity)
  • Range of motion (ROM)
    • Time Frame: Up to 4 weeks (baseline, 1 week, 2 weeks, 2 weeks + 1 day, 4 weeks)
    • Passive ROM of elbow, wrist and 3rd finger (in degrees: higher scores indicate larger range)
  • Grasp power
    • Time Frame: Up to 4 weeks (baseline, 2 weeks, 4 weeks)
    • Hand grip power (in Kg measured by a dynamometer: higher scores indicate stronger power)

Participating in This Clinical Trial

Inclusion Criteria

1. Spinal cord damage confirmed in the spinal cord image

2. 1 month after spinal cord injury

3. Spasticity of upper extremities

4. Pain in areas below spinal cord injury more than 4 points on the numerical scale (NRS)

5. Cognitive functions that can clearly point out NRS with more than 15 points in the mini mental state examination (MMSE)

6. Age: 20 and older

7. Person who has agreed in writing to decide his or her participation and comply with the precautions

Exclusion Criteria

1. Pain due to trauma

2. Injection treatments two weeks before participating in the study

3. Severe coagulopathy (excluding antiplatelet use)

4. Impaired cognition

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bundang CHA Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: MinYoung Kim, MD, PhD, Principal Professor of Rehabilitation Medicine – Bundang CHA Hospital
  • Overall Official(s)
    • Kyunghoon Min, MD, PhD, Principal Investigator, Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
  • Overall Contact(s)
    • Kyunghoon Min, MD, PhD, 82-30-780-1892, minkhrm@gmail.com

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